Indications, safety, and warnings for ProTrack™ Pigtail Wire

INDICATIONS FOR USE

The ProTrack™ Pigtail Wires are intended for use in percutaneous transseptal procedures to introduce and position catheters and other interventional devices within the left heart. The device is not intended for use in the coronary arteries.

CONTRAINDICATIONS

There are no known contraindications for this device.

WARNINGS

• The pigtail wire is intended for single use only. DO NOT resterilize and/or reuse.
• The pigtail wire should only be used by a physician trained in percutaneous, intravascular techniques and procedures. It is important to follow the instructions for use prior to using this product.
• The guidewire should only be handled by users who are familiar with aseptic handling techniques
• The pigtail wire is supplied sterile and non-pyrogenic in an unopened package and should be used under sterile conditions. DO NOT use if the package has been damaged or opened.
• DO NOT use the pigtail wire after the expiration date indicated on the label. Discard pigtail wires that exceed the expiration date.
• Confirm ancillary devices are compatible with the pigtail wire outer diameter before use.
• Always exercise care while advancing or withdrawing the pigtail wire to prevent wire breakage, kinking, coil separation or damage. Wire damage may cause complications which may require additional interventions.
• DO NOT push, auger, withdraw or torque a pigtail wire against resistance until the cause of the resistance has been determined. Applying excessive force against unexpected resistance may cause damage to the pigtail wire, interventional device and/or vessel/organ.
• Utilize proper techniques to prevent air from entering the catheter system while removing and reinserting the pigtail wire. Improper techniques could result in an air embolism.
• The Instructions for Use supplied with all interventional devices to be used in conjunction with Baylis Medical Pigtail wires should be consulted for intended use, contraindications, warnings, precautions and potential complications related to such devices.
• When the pigtail wire is exposed to the vascular system, it should be manipulated while under high-resolution imaging guidance including fluoroscopy and/or echocardiography. Improper visualization of the guidewire may lead to misplacement, dissection, or perforation.
• Inspect the pigtail wire prior to use for coil separation, kinking, appropriate distal tip flexibility or breakage. If the pigtail wire is damaged or defective, do not use it. Using a damaged or defective pigtail wire may cause vasculature damage and/or compromise pigtail wire performance.
• Guidewire must always be advanced/withdrawn through a compatible catheter.
• The curve of the pigtail wire is not designed to be reshaped and should be handled with care to avoid damaging the distal tip or device.
• Laboratory staff and patients can undergo significant X-ray exposure during interventional procedures due to the continuous usage of fluoroscopic imaging. The exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects. Therefore, adequate measures must be taken to minimize this exposure.
• DO NOT attempt to deliver electrical signals or RF energy through device
• Failure to abide by the warnings in this labeling might result in damage to the device, which may necessitate intervention or result in serious adverse events.

PRECAUTIONS

• DO NOT allow the pigtail wire to remain in a prolapsed position as this may result in damage to the pigtail wire.
• DO NOT straighten the spiral distal tip of the wire more than 5 times during a procedure.
• Use care when removing the pigtail wire from the dispenser to reduce the possibility of pigtail wire damage.

ADVERSE EVENTS

Potential complications associated with the use of the pigtail wire include, but are not limited to:

• Vessel Perforation/Dissection/Trauma or Damage
• Vessel Spasm
• Hemorrhage
• Access Site Complications/Hematoma
• Thrombus/Thromboembolism
• Allergic reaction
• Vascular complication
• Cardiac tamponade
• Cardiac Perforation/Laceration
• Conduction disorder
• Embolism
• Additional Surgical Procedure
• Pericardial/pleural effusion
• Sepsis/Infection/Inflammation
• Foreign Body/Wire Fracture
• Hemolysis
• Hypovolemia
• Myocardial Ischemia and/or Infarction
• Stroke/Transient Ischemic Attack
• Vessel Occlusion
• Wire Entrapment/Entanglement
• Valve Complication

97186432 (Rev. A)